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21 CFR 211: The Ten Fundamentals of CGMP

1)     Training – Subpart B: Organization of Personnel

  • Employees must have the education and experience necessary to perform their assigned roles
  • Personnel must be trained in the tasks and CGMP specific to their area of responsibility
  • There must be a documented record of training

The better trained a person is, the less likely that person is to make a mistake.

 

2)     Documentation and Recordkeeping – Subpart J: Records and Reports

Provides an “easy-to-follow” trail for the product, its components, equipment, and process at any point in time

 

3)     Written Procedures – Subpart J: Records and Reports

At least 2 dozen different types of documents and records are required by the pharmaceutical CGMP

  1. Standard Operating Procedures
  2. Batch Records
  3. Test Records
  4. Specification Forms
  5. Deviation Forms
  6. Equipment Cleaning & Maintenance Records

 

 

 

4)     Control and Identification of Materials – Subpart E: Control of Components, Drug Product Containers, and Closures

  • One of the fundamentals of CGMP is knowledge of the receipt, origin, identity, status, location, storage, and distribution of materials.
    1. All container contents must be identified – even trash cans must say “trash”

 

 

 

5)     Communication – Subpart B: Organization of Personnel

  • Written procedures (#3 on this list) form the basis of a good communication system.
  • It is crucial, and a requirement of the CGMP, to notify personnel of changes to procedures, practices, processes, specifications, and equipment function.

 

6)     Label Controls – Subpart G: Packaging and Label Control

  • There are numerous regulations requiring frequent inspection and accountability of labels, labeling equipment, labeling operations, label issuance, and label use.
  • The wrong label on a drug or device is a very serious issue, and may be a serious threat to the consumer.

7)     Contamination Controls – Subpart F: Production and Process Controls

These requirements are in place to help assure the quality, purity, and safety of the product.

Examples of requirements geared towards contamination control:

    1. Cleaning procedures
    2. Use of food-grade lubricants
    3. Pest Control
    4. Air-quality monitoring
    5. High-purity water systems

 

 

8)     Change Control – Subpart I: Industry Practices

  • Any deviations, laboratory investigations, or results that are out-of-specification must be investigated and fully documented. If needed, corrective actions should be implemented.
  • Any changes must be reported, evaluated, approved, implemented, and monitored.
    1. Any changes must also be communicated to personnel.

 

9)     Maintenance and Calibration – Subparts C and D: Buildings and Facilities, and Equipment

  • Processes can only be controlled by equipment that is properly maintained and functioning.
  • The accuracy of your test results can only be assured when the instruments are properly calibrated.

 

10)    Validation – Subpart I: Industry Practices

  • Provides documented evidence that a process does what it is supposed to
  • Regulations dictate what must be validated
    1. Computer systems and equipment
    2. Sterile processes
    3. Assay (testing) methods
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